Dose Ranging Study of Indacaterol in Japanese Patients With Chronic Obstructive Pulmonary Disease (COPD)

Novartis

Status and phase: Completed; Phase 2

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Drug: Indacaterol 150 μg; Drug: Placebo; Drug: Indacaterol 300 μg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00403845

CQAB149B1202

Details and patient eligibility

About

The study was designed to obtain data about the efficacy and safety of 3 doses of indacaterol (150, 300, and 600 µg) in Japanese patients with chronic obstructive pulmonary disease (COPD) so that optimal dose(s) could be chosen for testing in later studies.

Enrollment: 50 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and female Japanese aged 40 to 75 years old
• Moderate to severe chronic obstructive pulmonary disease (COPD) with smoking history of at least 20 pack years

Exclusion criteria

• History of hospitalization for COPD exacerbation within past 6 months
• Use of long-term oxygen therapy
• History of asthma
• Respiratory tract infection within past 1 month
• Consistently very high or low blood sugar
• Clinically abnormal laboratory values or significant condition
• History of heart failure or heart attack within past 6 months
• History of long QT syndrome or long QT interval in electrocardiogram recorded at screening

Other protocol-defined inclusion/exclusion criteria applied to the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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50 participants in 4 patient groups

Placebo-indacaterol 150μg-indacaterol 300μg-indacaterol 600μg

Experimental group

Description:

In treatment period, 1 patients received 2 placebo capsules; in treatment period 2, patients received 1 indacaterol 150 μg capsule + 1 placebo capsule; in treatment period 3, patients received 1 indacaterol 300 μg capsule + 1 placebo capsule; and in treatment period 4, patients received 2 indacaterol 300 μg capsules. There was a washout period of 14-28 days between each treatment period. Patients received each treatment only once. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.

Treatment:

Drug: Indacaterol 300 μg

Drug: Placebo

Drug: Indacaterol 150 μg

Indacaterol 150μg-indacaterol 600μg-placebo-indacaterol 300μg

Experimental group

Description:

In treatment period 1, patients received 1 indacaterol 150 μg capsule + 1 placebo capsule; in treatment period 2, patients received 2 indacaterol 300 μg capsules; in treatment period 3, patients received 2 placebo capsules; and in treatment period 4, patients received 1 indacaterol 300 μg capsule + 1 placebo capsule. There was a washout period of 14-28 days between each treatment period. Patients received each treatment only once. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.

Treatment:

Drug: Indacaterol 300 μg

Drug: Placebo

Drug: Indacaterol 150 μg

Indacaterol 300μg-placebo-indacaterol 600μg-indacaterol 150μg

Experimental group

Description:

In treatment period 1, patients received 1 indacaterol 300 μg capsule + 1 placebo capsule; in treatment period 2, patients received 2 placebo capsules; in treatment period 3, patients received 2 indacaterol 300 μg capsules; and in treatment period 4, patients received 1 indacaterol 150 μg capsule + 1 placebo capsule. There was a washout period of 14-28 days between each treatment period. Patients received each treatment only once. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.

Treatment:

Drug: Indacaterol 300 μg

Drug: Placebo

Drug: Indacaterol 150 μg

Indacaterol 600μg-indacaterol 300μg-indacaterol 150μg-placebo

Experimental group

Description:

In treatment period 1, patients received 2 indacaterol 300 μg capsules; in treatment period 2, patients received 1 indacaterol 300 μg capsule + 1 placebo capsule; in treatment period 3, patients received 1 indacaterol 150 μg capsule + 1 placebo capsule; and in treatment period 4 patients received 2 placebo capsules. There was a washout period of 14-28 days between each treatment period. Patients received each treatment only once. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.

Treatment:

Drug: Indacaterol 300 μg

Drug: Placebo

Drug: Indacaterol 150 μg